BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 1236122 · Received October 17, 2008

    Report

    Report Number
    2134243-2008-00008
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 16-SEP-2008, ACIST RECEIVED NOTIFICATION OF A USER FACILITY REPORT, REGARDING THE 2.5" MANIFOLD TUBING IN THE BT2000 MANIFOLD KIT DEVELOPING A BUBBLE IN THE TUBING DURING A CORONARY ANGIOGRAM. THE ACIST BT2000 MANIFOLD KIT, LOT 0928W, WAS RECEIVED BY ACIST ON 08-SEP-2008. INVESTIGATION AND TESTING WAS CONDUCTED ON 09-SEP-2008. ACIST VERIFIED THAT FLUID HAD INGRESSED BETWEEN THE TWO LAYERS OF THE 2.5" CO-EXTRUDED MANIFOLD TUBING, CAUSING A BUBBLE TO DEVELOP IN THE TUBING. THE BT2000 MANIFOLD KIT WAS TESTED USING A 4FR CATHETER AND RENO 60 CONTRAST MEDIA AND PUT THROUGH A SERIES OF INJECTIONS. THE BUBBLE IN THE TUBING INCREASED IN SIZE WITH EACH INJECTION. AFTER 51 INJECTIONS, THE BUBBLE RUPTURED. THERE WAS NO EVIDENCE OF AIR INGRESS INTO THE TUBING OR PIECES OF TUBING BREAKING OFF THE RUPTURED SECTION OF TUBING. PER ACIST'S COMPLAINT DATABASE, THE FAILURE RATE FOR THIS FAILURE MODE IS 3.8 OCCURRENCES PER 1,000,000 PROCEDURES. PER REVIEW BY ACIST'S MEDICAL ADVISORY BOARD, AND BASED ON THE RESULTS OF THE TESTING, THERE IS NO EVIDENCE OF A POTENTIAL FOR AIR INGRESS WITH THIS FAILURE MODE. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: THIS PRODUCT WAS USED IN CONJUNCTION WITH A CORONARY ANGIOGRAM. TUBING IN MANIFOLD SYSTEM DEVELOPED A BULGE IN THE TUBING. USE OF THE PRODUCT DISCONTINUED. NO APPARENT PROBLEMS, BUT COULD HAVE BEEN AN ISSUE IF TUBING COMPLETELY RUPTURED, WHICH WOULD HAVE RESULTED IN AIR IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST AUTOMATED PATIENT MANIFOLD KIT DXT ACIST MEDICAL SYSTEMS, INC. BT2000 0928W

    Patients

    Seq Age Sex Outcome Treatment
    1